Dovato, a single-tablet regimen containing dolutegravir and lamivudine, may be a good option for people starting antiretroviral therapy for the first time with CD4 T-cell counts below 200, according to data released this week. HIV drug therapy Meeting in Glasgow.
“We are encouraged by the addition of new data that continues to support the efficacy and safety of dual-drug therapy compared to traditional triple-drug therapy,” said Pedro Khan, MD, Ph.D., scientific director of Fuespedo Foundation in Buenos Aires. said. news release. “The DOLCE results will allow healthcare providers to prescribe with more confidence. [dolutegravir/lamivudine] This is an important finding for people living with HIV who take medications to suppress the virus. ”
ViiV Healthcare’s Dovato is currently available for use in HIV treatment-naive patients and those switching from another stable antiretroviral therapy with viral suppression, no history of treatment failure, and known viral mutations associated with dolutegravir resistance. Approved by the Food and Drug Administration for people who do not. or lamivudine.
TPhase IV DOLCE study (NCT04880395) evaluated the efficacy of Dovato in previously untreated adults with a CD4 count below 200, who were immunosuppressed and met diagnostic criteria for AIDS. The 230 participants in this open-label study were recruited at 11 centers in Argentina and Brazil and had no known antiretroviral resistance or co-infection with hepatitis B virus.
Participants were randomly assigned in a 2:1 ratio to receive either Dovato or dolutegravir (Tivicay) plus tenofovir disoproxil fumarate/emtricitabine (Truvada drug) or tenofovir alafenamide/emtricitabine (Descovy drug) It was done.
The regimens were equally effective at 48 weeks, with 82% of those in the Dovato group and 80% of those receiving the three-drug regimen having undetectable viral loads (less than 50). Viral suppression and time to CD4 cell recovery (increase of 200 vs. 177 cells, respectively) were also similar. Among people with high baseline viral loads (>500,000 copies), 74% in the Dovato group and 67% in the three-drug group achieved viral suppression. Post-hoc analysis showed that Dovato was non-inferior to triple therapy.
Treatment was safe and well tolerated. The incidence of serious adverse events and immune reconstitution inflammatory syndrome (symptoms of opportunistic infections worsen as the immune system recovers) was similar across groups. More people in the Dovato group discontinued treatment (13% vs. 7%), but the difference was not statistically significant.
In a separate Phase IV trial, researchers evaluated Dovato’s safety and efficacy in previously untreated people with no baseline HIV resistance results. The FDA’s indication for Dovato is limited to people with “no known alternatives related to resistance to individual ingredients,” but resistance testing may not be widely available in resource-limited settings.
Participants in the D2ARLING study (NCT04549467) were randomly assigned to receive Dovato or the same three-drug regimen used in DOLCE. Genotypic resistance testing was performed at the beginning of the trial, but the results were blinded and were not used to guide drug selection. At 48 weeks, Dovato was found to be non-inferior to triple therapy, confirming it as a viable option when resistance testing is not available.
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